Include the following. Other duties may be assigned.
Ordering of reference products, raw materials and packaging components required for the development of stable formulations.
Design experiments to develop a Robust formulation and manufacturing procedures for Sterile and Non-Sterile Liquid/Semisolid formulation with QbD approach.
Physico-Chemical characterization of the reference products and developed formulations.
Formulate laboratory test batches to support product development, regulatory submissions and the method validation program.
Independently manage product development requirements independently to meet the set project timeline.
Coordinate and track tasks involving analytical development, production, and regulatory affairs.
Develop protocols and procedures for product Scale up/Engineering batch, process verification and Exhibit Batches.
The Scientist is also responsible for documentation of the product development history and final product specifications along with Analytical Development Scientist.
Perform laboratory work to support product or process troubleshooting, special investigations and product complaints.
Assist in the general operation of the R & D formulation laboratory, including maintenance of SOP’s, training.
Support equipment purchase, validation and maintenance.
Maintain accurate and complete laboratory records as required by company policies and SOPs. Adherence and compliance to cGMP’s, GLPs and Data integrity is a must.
Assist other Formulation or Analytical Scientists in the development or preparation of drug products and samples.
Support and train Junior Scientists as deemed necessary.
Conduct peer review of laboratory notebooks and batch records.
Qualifications Bachelor of Science Degree (B. S.) in the life sciences or Chemistry fields from a four-year college or university with a minimum of 10 years related experience, or Master's degree with 7 years of related experience, or a Ph.D. with 5 years related experience.
Company Overview Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
EEO Statement Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.